FDA Committees Should Not Approve Dangerous So-Called Abuse-Deterrent Medications
July 26, 2017
FDA Committees Should Not Approve Dangerous So-Called Abuse-Deterrent Medication
Statement of Dr. Sidney Wolfe, Founding Director of and Senior Advisor to Public Citizen’s Health Research Group
Note: Today, two important U.S. Food and Drug Administration (FDA) committees will meet to discuss the approval of a new opioid medication to be marketed for moderate-to-severe pain. Dr. Sidney Wolfe provided testimony at the meeting.
If the Food and Drug Administration (FDA) advisory committees recommend and FDA agrees to approval of Intellipharmaceutics’ purportedly abuse-deterrent IPC oxycodone, it would set a dangerous precedent for other opioid painkillers. The company, contrary to current FDA guidelines, has never done any human abuse potential studies of this drug but seeks FDA approval to market its products as having properties that deter intravenous abuse. To say yes to approving this product is tantamount to saying no to the maximum effort to reduce the introduction of another opioid without attention to the lessons of the past. None of the current FDA-approved opioids with abuse-deterrent labeling were approved without pre-approval human abuse potential studies.